Duodenoscopes are flexible, lighted tubes that are threaded through the body into the top of the small intestine (duodenum) and allow doctors to see potential problems in the pancreas and bile ducts. Because duodenoscopes are reusable devices, they must be reprocessed (cleaned) after each use to ensure that tissue or fluid from one patient is not transferred when used on a subsequent patient.

For several years, FDA has been concerned about the reprocessing of duodenoscopes. In 2015, FDA required all manufacturers who make and sell duodenoscopes in the United States to conduct postmarket studies to allow FDA to better understand how duodenoscopes are reprocessed in real-world settings; in March of this year, FDA issued Warning Letters to all U.S. duodenoscope manufacturers for failing to meet their postmarket surveillance study requirements; and just this week, FDA provided interim results of the reprocessing studies and its recommendations.

Despite all this scrutiny, or maybe because it was already on the government’s radar, one of the manufacturers, Olympus Medical Systems Corporation, and its former quality manager were targeted for their failure to file reports related to known adverse events associated with its duodenoscopes. FDA requires medical device manufacturers to submit Medical Device Reports (MDRs) under 21 C.F.R. Part 803 for an event when they “become aware of that reasonably suggests that one of their marketed devices”:

(i) May have caused or contributed to a death or serious injury, or

(ii) Has malfunctioned and that the device or a similar device marketed by the manufacturer [or importer] would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

A failure to submit an MDR renders a medical device “misbranded,” and the FDC Act prohibits the introduction of a misbranded medical device into interstate commerce.

On December 10, 2018, Olympus agreed to plead guilty to three misdemeanor counts of introducing misbranded duodenoscopes into interstate commerce. The plea agreement contains a stipulation of facts describing Olympus’ receipt of information requiring submission of an initial or supplemental MDR, and requires the company to distribute to its U.S. customers a notice about the plea agreement. The company also is required to undertake certain compliance measures specific to MDR processes, akin to those contained in FDA civil consent decrees:

Retain an independent MDR expert to inspect and review the company’s policies and procedures;

Have the MDR expert conduct periodic reviews of the company’s continued compliance with MDR requirements;

Report to FDA and DOJ periodically for 3 years; and

Require the President and Board of Directors to periodically review MDR compliance measures and provide certifications to FDA and DOJ regarding those reviews.

The global settlement was authorized by DOJ’s Assistant Attorney General Joseph Hunt, which permitted the lead prosecutor from the U.S. Attorney’s Office in New Jersey to bind “the United States Attorney’s Offices for each of the other 93 judicial districts of the United States,” a provision that assures the company that another aggressive prosecutor will not bring follow-on charges against the company.

Hisao Yabe, the former Division Manager for the Quality Assurance and Environment Division, agreed to plead guilty to one count for the same conduct. He stipulated that he was aware of the obligation to file and supplement MDRs, and that he failed to make such submissions even when required. Interestingly, the stipulation notes that he considered whether to submit a supplemental MDR in 2013, but did not file it until 2015. In reviewing the underlying Information, it appears Yabe was in the process of evaluating whether the information it received in 2013 required reporting (e.g., whether the methodology and conclusions of the information were appropriate), and agreed that if a supplemental MDR was required, the company should file it. It is unclear, however, why the company waited until 2015 and what ultimately motivated the filing decision at that time. One can only speculate that the coincident timing of FDA scrutiny resulted in the MDR filing, which three years later, now forms the basis for the criminal charge.

In addition to the mandatory compliance measures, the company agreed to pay an $80 million criminal fine (which was 2.5 times the profit earned from the duodenoscopes sold during the time period), and a $5 million forfeiture. Yabe faces up to a year in prison and a $100,000 fine; he will be sentenced in March 2019.